Sharpoint Lukens Bone Wax
FDA 510(k) K050292 · Surgical Specialties Corp
510(k) numberK050292
Submission
- Device name
- Sharpoint Lukens Bone Wax
- Applicant
- Surgical Specialties Corp
Reading, PA, US - Received
- February 7, 2005
- Decision date
- March 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MTJ – Wax, Bone
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code MTJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | Orthocon, Inc. | 09/03/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 06/03/2026SE |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 10/12/2023SE |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 08/30/2023SE |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 07/11/2023SE |
| K200452 | Meril-BonewaxMTJ · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/27/2023SE |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 03/11/2022SE |
| K202363 | HBP7 Settable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 01/19/2021SE |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 03/27/2020SE |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ · Traditional | Orthocon, Inc. | 07/18/2019SE |
More from Orthocon, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160744 | LOOK PTFE SutureNBY · Traditional | 07/13/2016SE |
| K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignGAM · Special | 07/30/2014SE |
| K141625 | Polysyn Surgical SutureGAM · Special | 07/18/2014SE |
| K141558 | Quill Monoderm Knotless Tissue-Closure DeviceGAM · Special | 07/11/2014SE |
| K140227 | Monoderm Surgical SutureGAM · Special | 02/28/2014SE |
| K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)NEW · Special | 04/23/2008SE |
| K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneNEW · Special | 03/21/2008SE |
| K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture MaterialNEW · Traditional | 08/06/2007SE |
| K072028 | Quill Self-Retaining System (SRS) Comprised of MonodermGAM · Traditional | 08/03/2007SE |
| K063680 | Sharpoint Pdo (Polydioxanone) SuturesNEW · Traditional | 05/09/2007SE |
Questions and answers
When was Sharpoint Lukens Bone Wax cleared by the FDA?
Sharpoint Lukens Bone Wax (K050292) received a 510(k) decision of Substantially Equivalent on March 9, 2005, 30 days after the submission was received.
What is the product code of K050292?
The FDA product code is MTJ – Wax, Bone, a Unclassified device.